510(k) · Cleared
ClearedPrizma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G-Medical Innovations, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 1, 2017 as substantially equivalent to K083174 (Card Guard Scientific Survival, Ltd., 2009) and 1 other predicate after a 225-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Sep 1, 2017
- Review
- 225 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962603 (1997). 21 ancestors in all, the oldest K863918 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- 1 generation backK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- This deviceK170181 PrizmaG-Medical Innovations, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK173589 PrizmaG-Medical Innovations, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173589PrizmaG-Medical Innovations, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| −1 | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| 0 (this device) | K170181 | Prizma | G-Medical Innovations, Ltd. | 2017 | — |
| +1 | K173589 | Prizma | G-Medical Innovations, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083174 | HealthepodSummary page 4…870.2700 Oximeter Regulatory Class: 2 Product Code: DXH, DQA, FLL PREDICATE DEVICES Card Guard Scientific Survival, Health-ePod, K083174 SpO Medical, PulseOx 5500 Finger Device, K040178 Radiometer, OSM-3 Hemoximeter, K853990 (reference device in oximeter trial) DE… | 2009 |
| * | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceSummary page 4…2 Product Code: DXH, DQA, FLL PREDICATE DEVICES Card Guard Scientific Survival, Health-ePod, K083174 SpO Medical, PulseOx 5500 Finger Device, K040178 Radiometer, OSM-3 Hemoximeter, K853990 (reference device in oximeter trial) DEVICE DESCRIPTION The Prizma is designed in the f… | 2004 |
| † | K853990 | OSM3 Hemoximeter | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173589 | Prizma | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K173589 (G-Medical Innovations, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083174.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Prizma device is indicated to measure, record and transmit ECG one-lead data, and to measure, record, display and transmit heart rate, peripheral oxygen saturation and skin temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. The device does not perform diagnostic functions.
Intended population: adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170181: Prizma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170181
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026